Utility of ICD Electrograms During Ventricular Tachycardia Ablation
Primary Purpose
Sustained Monomorphic Ventricular Tachycardia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional RF catheter ablation
Investigational RF Catheter Ablation using ICD-EG information
Sponsored by
About this trial
This is an interventional treatment trial for Sustained Monomorphic Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Clinical indication for RF catheter ablation
- Presence of an implanted ICD
- At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram
- Presence of structural heart disease
- Able to obtain signed informed consent and willing to comply with study activity requirements
Exclusion Criteria:
- It is anticipated that data can not be obtained during follow-up
- Unwilling or unable to provide informed consent
- Women who are or may potentially be pregnant
- Patients who are participating in another clinical trial
Sites / Locations
- Hospital General Universitario
- Hospital de la Santa Creu i Sant Pau
- Hospital del Mar
- Hospital Universitario de Basurto
- Hospital Universitario de Burgos
- Hospital Universitario Virgen de las Nieves
- Hospital Universitario Insular de Gran Canaria
- HM Hospitales
- Hospital Universitario La Paz
- Hospital Universitario Ramón y Cajal
- Hospital Universitario Virgen de la Arrixaca
- Hospital Universitario Nuestra Señora de Valme
- Hospital Virgen de la Salud
- Hospital Clínico Universitario
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Conventional RF catheter ablation
Investigational RF Catheter Ablation using ICD-EG information
Arm Description
Conventional RF ablation will be performed without using ICD-EG information
RF Catheter Ablation will be performed using ICD-EG information
Outcomes
Primary Outcome Measures
Percentage of patients free of VT recurrence
Secondary Outcome Measures
Reduction in number of VT recurrence
Reduction in the proportion of patients free of VT recurrence
Reduction in the proportion of patients free of recurrence in patients in whom 12-lead ECG of the spontaneous VT is not available and in those in whom hemodinamically tolerated VT is not induced
Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added
This outcome will be studied from the stored signal together with the ICD-EG on the device in the subgroup of patients with a device that allows to obtain this parameter. In the remaining patients, signals will be obtained noninvasively with a seismocardiogram using a highly sensitive accelerometer located in the sternal midline of the xiphoid process and simultaneously synchronized with the ECG.
Full Information
NCT ID
NCT02274168
First Posted
September 14, 2014
Last Updated
December 9, 2022
Sponsor
Fundación Hospital de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02274168
Brief Title
Utility of ICD Electrograms During Ventricular Tachycardia Ablation
Official Title
Aid of Recording ICD Electrograms During Monomorphic Ventricular Tachycardia Ablation Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
March 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Hospital de Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
With the increasing use of implantable cardioverter defibrillators (ICD) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an ICD is in place and the only documentation of the clinical arrhythmia will be the ICD electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained monomorphic VT represents a limitation when performing treatment with radiofrequency (RF) ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a reference "model" of VT with clinical expression consisting of the electrical signal of the ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This will allow for a more targeted approach to the substrate of the VT with clinical expression because: 1) if VT is induced by programmed stimulation, one can tell whether it is with clinical expression or not, and 2) if VT is not induced, ventricular pacing could be performed based on the comparative analysis of morphology and activation times of ICD-EG. These approaches will result in improved outcomes of the ablation procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sustained Monomorphic Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional RF catheter ablation
Arm Type
Other
Arm Description
Conventional RF ablation will be performed without using ICD-EG information
Arm Title
Investigational RF Catheter Ablation using ICD-EG information
Arm Type
Other
Arm Description
RF Catheter Ablation will be performed using ICD-EG information
Intervention Type
Procedure
Intervention Name(s)
Conventional RF catheter ablation
Intervention Description
RF catheter ablation will be performed as usually done by each center. No ICD EGMs will be obtained and used during the ablation procedure (do not place the programming head over the ICD generator).
Intervention Type
Procedure
Intervention Name(s)
Investigational RF Catheter Ablation using ICD-EG information
Intervention Description
RF ablation procedure will be performed with the programming head over the ICD generator. ICD EGMs will be registered every time VT is induced and during ventricular pacing. ICD EGMs obtained during ablation procedure will be compared with the EGMs of the registered spontaneus VT and used to locate appropriate ablation sites.
Primary Outcome Measure Information:
Title
Percentage of patients free of VT recurrence
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reduction in number of VT recurrence
Time Frame
6 months
Title
Reduction in the proportion of patients free of VT recurrence
Time Frame
6 months
Title
Reduction in the proportion of patients free of recurrence in patients in whom 12-lead ECG of the spontaneous VT is not available and in those in whom hemodinamically tolerated VT is not induced
Time Frame
6 months and total follow-up
Title
Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added
Description
This outcome will be studied from the stored signal together with the ICD-EG on the device in the subgroup of patients with a device that allows to obtain this parameter. In the remaining patients, signals will be obtained noninvasively with a seismocardiogram using a highly sensitive accelerometer located in the sternal midline of the xiphoid process and simultaneously synchronized with the ECG.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Clinical indication for RF catheter ablation
Presence of an implanted ICD
At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram
Presence of structural heart disease
Able to obtain signed informed consent and willing to comply with study activity requirements
Exclusion Criteria:
It is anticipated that data can not be obtained during follow-up
Unwilling or unable to provide informed consent
Women who are or may potentially be pregnant
Patients who are participating in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Almendral, MD
Organizational Affiliation
HM Hospitales
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General Universitario
City
Alicante
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Basurto
City
Bilbao
Country
Spain
Facility Name
Hospital Universitario de Burgos
City
Burgos
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Hospital Universitario Insular de Gran Canaria
City
Las Palmas
Country
Spain
Facility Name
HM Hospitales
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Universitario Nuestra Señora de Valme
City
Sevilla
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Valencia
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20828650
Citation
Yoshida K, Liu TY, Scott C, Hero A, Yokokawa M, Gupta S, Good E, Morady F, Bogun F. The value of defibrillator electrograms for recognition of clinical ventricular tachycardias and for pace mapping of post-infarction ventricular tachycardia. J Am Coll Cardiol. 2010 Sep 14;56(12):969-79. doi: 10.1016/j.jacc.2010.04.043.
Results Reference
background
PubMed Identifier
20828651
Citation
Almendral J, Marchlinski F. Is it the same or a different ventricular tachycardia?: an additional use for defibrillator electrograms. J Am Coll Cardiol. 2010 Sep 14;56(12):980-2. doi: 10.1016/j.jacc.2010.03.081. No abstract available.
Results Reference
background
PubMed Identifier
22151407
Citation
Almendral J, Atienza F, Everss E, Castilla L, Gonzalez-Torrecilla E, Ormaetxe J, Arenal A, Ortiz M, Sanroman-Junquera M, Mora-Jimenez I, Bellon JM, Rojo JL. Implantable defibrillator electrograms and origin of left ventricular impulses: an analysis of regionalization ability and visual spatial resolution. J Cardiovasc Electrophysiol. 2012 May;23(5):506-14. doi: 10.1111/j.1540-8167.2011.02233.x. Epub 2011 Dec 8.
Results Reference
background
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Utility of ICD Electrograms During Ventricular Tachycardia Ablation
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